The effect of a novel vaginal ring delivering oestradiol acetate on climacteric symptoms in postmenopausal women

Abstract

Evaluate the efficacy and acceptability of a novel vaginal ring delivering oestradiol acetate (Menoring) versus oral oestradiol for relief of climacteric symptoms in postmenopausal women. Prospective, multicentre, randomised, double-blind, comparator-controlled, parallel group study. Twenty-one centres in the United Kingdom. Postmenopausal women, aged <65 years experiencing > or =20 hot flushes/night sweats per week for two consecutive weeks. Patients received a vaginal ring releasing oestradiol acetate at a rate equivalent to 50 microg/day in addition to placebo tablets (vaginal ring group) or oral oestradiol 1 mg/day in addition to placebo vaginal ring (oral group) for 24 weeks. For patients with inadequate control of vasomotor symptoms, dosage was doubled at 12 weeks. Non-hysterectomised women received norethisterone 1 mg/day for 12 days in each 28 day cycle. Efficacy was assessed by change in climacteric symptoms measured by the Greene Climacteric Scale, as well as mean change in frequency of hot flushes/night sweats. A total of 159 patients were enrolled (84 vaginal ring, 75 oral). Significant improvement (P < 0.05) in mean total Greene Climacteric Scale scores in both treatment groups was observed at 12 and 24 weeks and for every subscale score including anxiety, depression and sexual dysfunction (P < 0.05). In both groups, frequency of hot flushes/night sweats was significantly reduced (P < 0.001) at 12 and 24 weeks. No significant between-group differences were noted at 12 or 24 weeks. The oestradiol vaginal ring significantly improved climacteric symptoms as measured by Greene Climacteric Scale scores and reduced the frequency of hot flushes/night sweats. Efficacy and safety of vaginal ring oestradiol were comparable with those of oral therapy. Patient evaluations of oestradiol vaginal ring tolerability and acceptability were excellent.